Last updated: 11/03/2018 11:17:52
Immunogenicity & safety study of GSK Biologicals’ combined measles-mumps-rubella-varicella vaccine 208136
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity & safety study of GSK Biologicals’ combined measles-mumps-rubella-varicella vaccine 208136
Trial description: This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroconverted for measles, mumps, rubella and varicella zoster virus (VZV) antibodies above the cut-off values
Timeframe: At 42 days post-vaccination
Secondary outcomes:
Antibody concentrations against measles
Timeframe: At 42-days post-vaccination
Antibody concentrations against mumps
Timeframe: At 42-days post-vaccination
Antibody concentrations against rubella
Timeframe: At 42-days post-vaccination
Antibody titers against varicela viruses
Timeframe: At 42-days post-vaccination
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: During the 43-day (Days 0-42) post-vaccination period
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within the 43-day (Days 0-42) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 up to Day 43 or Day 57)
Interventions:
Biological/vaccine: PriorixTM
Biological/vaccine: VarilrixTM
Biological/vaccine: Priorix-Tetra®
Enrollment:
475
Observational study model:
Not applicable
Primary completion date:
2010-27-05
Time perspective:
Not applicable
Clinical publications:
Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.
Cha SH et al. (2014) Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children. Clin Exp Vaccine Res. 3(1):91-99.
Medical condition
Measles, Varicella, Mumps, Rubella
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
October 2008 to May 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 24 months
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- History of measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
- Residence in the same household as a high risk person e.g.: − New-born infants (0-4 weeks of age) − Pregnant women who have a negative history of chickenpox − Persons with known immunodeficiency
Trial location(s)
Location
GSK Investigational Site
Seongnam-si, Gyeonggi-do, South Korea, 463-712
Status
Study Complete
Location
GSK Investigational Site
GyeongSangNam-do, South Korea, 641-560
Status
Study Complete
Location
GSK Investigational Site
Wonju-si Kangwon-do, South Korea, 220-701
Status
Study Complete
Location
GSK Investigational Site
Uijeongbu, Kyonggi-do, South Korea, 480-130
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-27-05
Actual study completion date
2010-27-05
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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