Investigational varicella vaccine
BiologicalInvestigational varicella vaccine administered subcutaneously.
NCT Number: NCT06806137
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.
Interested in participating?
Request Info12 month–15 month
All sexes
Interventional
Phase 3
GSK Investigational Site, Salvaleón de Higüey, La Altagracia Province, Dominican Republic
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
i) For corticosteroids, this will mean prednisone equivalent >=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
ii) Administration of immunoglobulins and/or any blood products or plasma derivatives.
i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation.
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.
Time frame: At Day 133 (43 days post-dose 2)
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 (within 43 days post-dose 2)
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)
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)
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
Time frame: Day 1 (post-dose 1) to Day 4
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 91 (post-dose 2) to Day 94
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 1 (post-dose 1) to Day 15
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 91 (post-dose 2) to Day 105
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 1 (post-dose 1) to Day 22
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 91 (post-dose 2) to Day 112
Fever is defined as temperature >=38.0 degrees °C by any route (the preferred location for measuring temperature is the axilla).
Time frame: Day 1 (post-dose 1) to Day 43
Solicited administration site include injection site varicella-like rash.
Time frame: Day 91 (post-dose 2) to Day 133
Solicited administration site include injection site varicella-like rash.
Time frame: Day 1 (post-dose 1) to Day 43
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
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
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
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 271 (study end)
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)
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.
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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