The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.
The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).
The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.
Inclusion Criteria (INC):
Exclusion Criteria (EXC):
EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.
EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
EXC#3 Hypersensitivity to latex.
EXC#4 Unstable chronic conditions as determined by medical history and physical examination.
EXC#5 Major congenital defects, as assessed by the investigator.
EXC#6 History of measles, mumps, rubella or varicella/zoster disease as evaluated by the investigator.
EXC#7 History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
EXC#8 Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures (including all subtypes, such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).
EXC#9 Active untreated tuberculosis.
EXC#10 Condition that, in the judgment of the investigator, would make intramuscular injection unsafe.
EXC#11 Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
EXC#12 Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
EXC#13 Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
EXC#14 Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
Up to 90 days prior to the study interventions administration.
Up to 180 days prior to study interventions administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study interventions, e.g., nirsevimab), antitumoral medication.
EXC#15 Previous vaccination with a second dose of varicella-containing vaccine or measles, mumps, rubella containing vaccine.
EXC#16 Vaccination against diphtheria, tetanus, pertussis, and/or poliomyelitis given after the second year of life (i.e., after the second birthday at 24 months of age).
EXC#17 Occurrence of any of the following events after a previous administration of DTP vaccine:
EXC#18 Use of salicylates (aspirin) or salicylate-containing products or its planned use, during the period of 6 weeks following study interventions administration.
EXC#19 Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration* (Visit 2), with the exception of
Influenza vaccines:
Inactivated influenza vaccine must not be administered in the period starting 28 days before the dose and ending 28 days after the dose of study intervention administration. If administered outside this prohibited period, it should be administered at a different location than the study intervention.
Live attenuated influenza vaccine must not be administered during the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration (Visit 2).
If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.
EXC#20 Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/vaccine/invasive medical device).
EXC#21 Any study personnel's immediate dependents, family, or household members.
EXC#22 Child in care.
EXC#23 Participants with the following high-risk individuals in their household:
GSKClinicalSupportHD@gsk.com
This is an observer-blind study. In an observer-blind study, the participant, the site, and Sponsor personnel involved in the clinical evaluation of the participants are blinded while other study personnel may be aware of the treatment assignment.
Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
GSKClinicalSupportHD@gsk.com+44 (0) 20 89904466
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