Last updated: 11/03/2018 09:07:36
Immunogenicity/safety of measles-mumps-rubella-varicella vaccine (MeMuRu-OKA): using two different administration routes
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Open, multicenter, randomised, controlled phase IIIb study evaluating the immunogenicity and safety of subcutaneous versus alternative administration route of combined MeMuRu-OKA vaccine to healthy children aged 11 to 21 months.
Trial description: This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of seroconverted subjects with varicella zoster virus (VZV) antibody titer above or below cut-off value
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Secondary outcomes:
Anti-VZV antibody titers
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Frequency of varicella-specific Cluster of Differentiation 4 (CD4+) and CD8+ T-cell responses
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Frequency of measles-specific CD4+ and CD8+ T-cell responses
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Frequency of mumps-specific CD4+ and CD8+ T-cell responses
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Percentage of seroconverted subjects anti-measles, anti-mumps and anti-rubella antibody titers above or below cut-off value
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Anti-measles, anti-mumps and anti-rubella antibody titers
Timeframe: At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
Number of subjects with immediate vaccination pain assessed by scores on the VAS
Timeframe: Immediately before vaccination (i.e. at Day 0 and Week 6)
Number of subjects with immediate vaccination pain assessed by scores on the Visual Analogue Scale (VAS)
Timeframe: 30 seconds after each vaccination (i.e. at Day 0 and Week 6)
Number of subjects with any and grade 3 solicited local adverse events (AEs)
Timeframe: During the 4-day follow-up period after each vaccination
Number of subjects with any, grade 3 and vaccine-related solicited general AEs
Timeframe: During the 43-day follow-up period after each vaccination
Number of subjects with any, grade 3 and vaccine-related unsolicited AEs
Timeframe: During the 43-day follow-up period after each vaccination
Number of subjects with any serious adverse events (SAEs)
Timeframe: Throughout the entire study period (Day 0 up to Week 12)
Interventions:
Vaccine: MeMuRu-OKA (study vaccine)
Biological/vaccine: MeMuRu-OKA (study vaccine)
Enrollment:
330
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Knuf M et al. Safety, tolerability and immediate pain after subcutaneous versus intramuscular administration of a measles-mumps-rubella-varicella 5MMRV) vaccine to children aged 11-21 months. Abstract presented at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Graz, Austria, 13-17 May 2008.
Medical condition
Measles, Mumps, Rubella, Varicella
Product
SB208136
Collaborators
Not applicable
Study date(s)
March 2006 to December 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 22 months
Accepts healthy volunteers
Yes
- Children must be healthy and have a birth weight > 2000 g to participate
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Children must be healthy and have a birth weight > 2000 g to participate
Exclusion criteria:
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
- Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
- Children must not have had measles, mumps, rubella or varicella/zoster, 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
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schöneberg - Kübelberg, Rheinland-Pfalz, Germany, 66901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60389
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68309
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Gerolstein, Rheinland-Pfalz, Germany, 54568
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55127
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55129
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-13-12
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.
Additional information about the trial
Additional information
Not applicable
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