This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
900
Investigational varicella vaccine administered intramuscularly.
Marketed varicella vaccine administered subcutaneously.
MMR vaccine administered subcutaneously or intramuscularly.
Hepatitis A vaccine co-administered intramuscularly.
The 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.
The 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.
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
GSK Investigational Site
Tucson, Arizona, United States
RECRUITINGGSK Investigational Site
Huntington Park, California, United States
RECRUITINGGSK Investigational Site
Sherman Oaks, California, United States
RECRUITINGGSK Investigational Site
Coral Gables, Florida, United States
RECRUITINGGSK Investigational Site
Miami Lakes, Florida, United States
RECRUITINGGSK Investigational Site
Tampa, Florida, United States
RECRUITINGGSK Investigational Site
Idaho Falls, Idaho, United States
RECRUITINGGSK Investigational Site
Dayton, Ohio, United States
RECRUITINGGSK Investigational Site
Houston, Texas, United States
RECRUITINGGSK Investigational Site
Lewisville, Texas, United States
RECRUITING...and 2 more locations
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
Time frame: At Day 43
Geometric Mean Concentration (GMC) of anti-VZV gE IgG
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
Time frame: At Day 43
Percentage of participants with seroresponse to MMR antigens
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
Time frame: At Day 43
GMC of Anti-measles antibodies
Time frame: At Day 43
GMC of Anti-mumps antibodies
Time frame: At Day 43
GMC of Anti-rubella antibodies
Time frame: At Day 43
Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine
Time frame: At Day 43
Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin
Time frame: At Day 43
Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration
Solicited administration site events include injection site redness, pain, and swelling.
Time frame: Day 1 (post-dose) to Day 4
Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 1 (post-dose) to Day 4
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 1 (post-dose) to Day 15
Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration
Fever is defined as temperature greater than or equal (\>=) 38.0 degrees Celsius (°C) regardless of the location of measurement (the preferred location for measuring temperature is the axilla).
Time frame: Day 1 (post-dose) to Day 22
Percentage of participants reporting each solicited administration site events post-dose of study interventions administration
Solicited administration site events include injection site varicella-like rash.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
Solicited systemic events includes varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella like and not measles/rubella-like).
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration
Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines. Unsolicited AEs include nonserious and serious AEs.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
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