The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.
The study aims to demonstrate the immunogenicity of the investigational VNS vaccine at three potencies (VNS\_Low, VNS\_Med, and VNS\_High) compared to the licensed varicella vaccine, Varivax (VV), as a first dose for children aged 12 to 15 months in the US. To ensure more representative data, participants in the VV group are randomized into two lots (VV\_Lot1 and VV\_Lot2), which are analyzed as pooled lots throughout the study. Besides assessing immunogenicity, the study also seeks to generate safety data. In the US, participants will receive additional vaccines: a measles, mumps, and rubella vaccine (MMR), a hepatitis A vaccine (Havrix), and a 13-valent pneumococcal conjugate vaccine (Prevnar 13). Participants outside the US will receive an MMR vaccine (M-M-R II or M-M-RVaxPro, depending on the country), Havrix, and, in some cases, Prevnar 13, but only in countries where it's recommended for children 12-15 months according to local immunization schedules. At the end of the study, or shortly after, GSK provided re-vaccination with a dose of Varivax (VV) to participants who did not meet the pre-specified seroresponse threshold of anti-gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL. Additionally, a second dose of VV and/or Havrix was offered to participants in non-US countries where local health departments do not routinely provide varicella and/or hepatitis A vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
800
1 dose of a low-potency investigational varicella vaccine administered subcutaneously.
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies
Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.
Time frame: At Day 43
Percentage of Participants With Seroresponse to VZV gE
Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL for each group.
Time frame: At Day 43
Number of Participants Reporting Each Solicited Administration Site Events
Assessed solicited administration site events included injection site redness, pain and swelling.
Time frame: Day 1 (post dose) to Day 4
Number of Participants Reporting Each Solicited Systemic Events
Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature \>= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash.
Time frame: Day 1 (post dose) to Day 43
Number of Participants Reporting Each Solicited Systemic Events
Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.
Time frame: Day 1 (post dose) to Day 15
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1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.
1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
1 dose of a hepatitis A vaccine administered intramuscularly.
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
GSK Investigational Site
Bryant, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Bellflower, California, United States
GSK Investigational Site
Downey, California, United States
GSK Investigational Site
Foothill Ranch, California, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Tampa, Florida, United States
...and 41 more locations
Number of Participants Reporting Unsolicited Adverse Events
Unsolicited adverse events (AEs) included 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; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs.
Time frame: Day 1 (post dose) to Day 43
Number of Participants Reporting Serious Adverse Events (SAEs)
A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment.
Time frame: From Day 1 to Day 181 (Study end)