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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
Investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine administered subcutaneously.
MMR vaccine co-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 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.
GSK Investigational Site
Salvaleón de Higüey, La Altagracia Province, Dominican Republic
RECRUITINGGSK Investigational Site
Constanza, Dominican Republic
RECRUITINGGSK Investigational Site
Santo Domingo Oeste, Dominican Republic
RECRUITINGGSK Investigational Site
San Pedro Sula, Honduras
RECRUITINGGSK Investigational Site
Tegucigalpa, Honduras
RECRUITINGGSK Investigational Site
Tegucigalpa, Honduras
RECRUITINGPercentage 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).
Time frame: At Day 133 (43 days post-dose 2)
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.
Time frame: At Day 133 (within 43 days post-dose 2)
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.
Time frame: At Day 133 (within 43 days post-dose 2)
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.
Time frame: At Day 133 (within 43 days post-dose 2)
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 1 (post-dose 1) to Day 4
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 91 (post-dose 2) to Day 94
Percentage of participants reporting each solicited systemic event
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 1 (post-dose 1) to Day 15
Percentage of participants reporting each solicited systemic event
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 91 (post-dose 2) to Day 105
Percentage of participants reporting each solicited systemic event in terms of fever
Fever is defined as temperature \>=38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla).
Time frame: Day 1 (post-dose 1) to Day 22
Percentage of participants reporting each solicited systemic event in terms of fever
Fever is defined as temperature \>=38.0 degrees °C by any route (the preferred location for measuring temperature is the axilla).
Time frame: Day 91 (post-dose 2) to Day 112
Percentage of participants reporting each solicited administration site event
Solicited administration site include injection site varicella-like rash.
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited administration site event
Solicited administration site include injection site varicella-like rash.
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting each solicited systemic event
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited systemic event
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting unsolicited adverse events (AEs)
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.
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting unsolicited adverse events (AEs)
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.
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting medically attended AEs (MAAE)
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 1) to Day 271 (study end)
Percentage of participants reporting serious adverse events (SAEs)
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 1) to Day 271 (study end)
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