About this trial
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant's parent(s) Legally acceptable representatives /(LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.
Disqualifiers
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Hypersensitivity to latex.
Major congenital defects, as assessed by the investigator.
Trial design
Parallel
Treatments tested in this trial
Investigational varicella vaccine_Lot 1
Biological/VaccineInvestigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine_Lot 2
Biological/VaccineInvestigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine_Lot 3
Biological/VaccineInvestigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine_Lot 1
Biological/VaccineMarketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine_Lot 2
Biological/VaccineMarketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine
Biological/VaccineMMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Biological/VaccineHepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
Biological/VaccineThe 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
Biological/VaccineThe 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
Biological/VaccineThe Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \[(antibody concentration less than (\<) LLOQ (Lower limit of quantification)\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \>= 300 mIU/mL among participants who were seronegative (antibody concentration \< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
Secondary outcomes
Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-measles will be defined by the laboratory before the analysis.
Sponsors and contacts
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