Last updated: 10/30/2019 12:10:57
Immunogenicity & safety study of GSK Biologicals’ 208136 vaccine formulated with new measles and rubella working seeds
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity & safety study of GSK Biologicals’ 208136 vaccine formulated with new measles and rubella working seeds
Trial description: This study is undertaken to generate clinical data on GSK Biologicals’ combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies greater than or equal to (≥) the cut-off value.
Timeframe: At 42-56 days after the first dose of study vaccine (Week 6)
Secondary outcomes:
Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies ≥ the cut-off value.
Timeframe: At 42-56 days after the second dose of study vaccine (Week 18)
Antibody titers against measles, mumps, rubella and varicella viruses
Timeframe: At 42-56 days after the first and second dose of study vaccine(s).
Number of subjects reporting any and grade 3 solicited local symptoms
Timeframe: Within 4 days after each vaccination (Days 0-3)
Number of subjects reporting any and grade 3 solicited general symptoms
Timeframe: Within 43 days (Days 0-42) after each vaccination
Number of subjects reporting any, grade 3 and related fever
Timeframe: Within 43 days (Days 0-42) after each vaccination
Number of subjects reporting any (local or general), grade 3 and related rashes
Timeframe: Within 43 days (Days 0-42) after each vaccination
Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs)
Timeframe: Within 43 days (Days 0-42) after first vaccination dose
Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs)
Timeframe: Within 43 days (Days 86-128) after second vaccination dose
Number of subjects with serious adverse events (SAEs)
Timeframe: From first study dose (Day 0) until study end (Week 18)
Interventions:
Biological/vaccine: Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)
Biological/vaccine: GSK Biologicals’ 208136, new formulation
Enrollment:
501
Observational study model:
Not applicable
Primary completion date:
2010-17-09
Time perspective:
Not applicable
Clinical publications:
Huang LM et al. (2013) Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: A phase II, randomized, double-blind trial. Hum Vaccin Immunother. 9(6). [Epub ahead of print]
Medical condition
Measles, Varicella, Mumps, Rubella
Product
SB208136
Collaborators
Not applicable
Study date(s)
June 2009 to December 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 21 months
Accepts healthy volunteers
Yes
- .
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
- Free of obvious healthy problems 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 first 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 first 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 each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each 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.
- History of any neurologic disorders or seizures.
- 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)
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
2010-17-09
Actual study completion date
2010-13-12
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.
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