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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
750
1 dose of investigational varicella vaccine administered subcutaneously.
1 dose of marketed varicella vaccine administered subcutaneously.
1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
Percentage of participants reporting each solicited administration site events
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 event
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
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).
Time frame: Day 1 (post-dose) to Day 22
Percentage of participants reporting each solicited administration site events
Solicited administration site include injection site varicella-like rash.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting solicited systemic events
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: Day 1 (post-dose) to Day 43
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1 dose of hepatitis A vaccine co-administered intramuscularly.
1 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.
1 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.
1 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.
GSK Investigational Site
Phoenix, Arizona, United States
WITHDRAWNGSK Investigational Site
Tucson, Arizona, United States
WITHDRAWNGSK Investigational Site
Huntington Park, California, United States
RECRUITINGGSK Investigational Site
National City, California, United States
RECRUITINGGSK Investigational Site
West Covina, California, United States
RECRUITINGGSK Investigational Site
Hialeah, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Chicago, Illinois, United States
RECRUITINGGSK Investigational Site
El Dorado, Kansas, United States
WITHDRAWNGSK Investigational Site
Lafayette, Louisiana, United States
RECRUITING...and 36 more locations
Time frame: Day 1 (post-dose) to Day 181 (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) to Day 181 (study end)