About this trial
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and 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 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 (no laboratory testing required).
Hypersensitivity to latex.
Recurrent history of uncontrolled neurological disorders or seizures.
Trial design
Parallel
Treatments tested in this trial
Investigational varicella vaccine
Biological/Vaccine1 dose of investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine
Biological/Vaccine1 dose of marketed varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine
Biological/Vaccine1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Biological/Vaccine1 dose of hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
Biological/Vaccine1 dose of 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/Vaccine1 dose of 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/Vaccine1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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 reporting each solicited administration site events
Solicited administration site events include injection site redness, pain and swelling.
Percentage of participants reporting each solicited systemic event
Solicited systemic events include drowsiness, loss of appetite and irritability.
Percentage of participants reporting each solicited systemic event in terms of fever
Fever is defined as temperature greater than or equal to (\>=) 38.0°C (100.4°F) by any route (the preferred location for measuring temperature is the axilla).
Percentage of participants reporting each solicited administration site events
Solicited administration site include injection site varicella-like rash.
Sponsors and contacts
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