About this trial
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
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 the first 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
Biological/VaccineInvestigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine
Biological/VaccineMarketed varicella vaccine 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) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\>=) 300 milli-international units per milliliter (mIU/mL).
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
Secondary outcomes
Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti-VZV gE IgG concentration \>= 300 mIU/mL.
GMC of anti-VZV gE IgG for VV-VNS group
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Sponsors and contacts
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