A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
Investigational varicella vaccine_Lot 1: Investigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine_Lot 2: Investigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine_Lot 3: Investigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine_Lot 1: Marketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine_Lot 2: Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine: MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine: Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13: 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.
PCV 20: 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.
Vaxneuvance: 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.
Study summary
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
Eligibility
Primary outcome measure(s)
- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups — At Day 43
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \[(antibody concentration less than (\<) LLOQ (Lower limit of quantification)\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. - Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups — At Day 43
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group. - Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups — At Day 43
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \>= 300 mIU/mL among participants who were seronegative (antibody concentration \< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. - GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups — At Day 43
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
Trial sites (97)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | Recruiting |
| GSK Investigational Site | Hot Springs | Arkansas | Recruiting |
| GSK Investigational Site | Sherwood | Arkansas | Recruiting |
| GSK Investigational Site | Canoga Park | California | Recruiting |
| GSK Investigational Site | Covina | California | Recruiting |
| GSK Investigational Site | Fullerton | California | Withdrawn |
| GSK Investigational Site | Long Beach | California | Withdrawn |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Paramount | California | Withdrawn |
| GSK Investigational Site | Sacramento | California | Recruiting |
| GSK Investigational Site | Ventura | California | Recruiting |
| GSK Investigational Site | Walnut Creek | California | Recruiting |
| GSK Investigational Site | Winnetka | California | Recruiting |
| GSK Investigational Site | Miami | Florida | Withdrawn |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami Lakes | Florida | Recruiting |
| GSK Investigational Site | Spring Hill | Florida | Recruiting |
| GSK Investigational Site | Tampa | Florida | Recruiting |
| GSK Investigational Site | Covington | Georgia | Recruiting |
| GSK Investigational Site | Ammon | Idaho | Recruiting |
| GSK Investigational Site | Moline | Illinois | Recruiting |
| GSK Investigational Site | South Bend | Indiana | Recruiting |
| GSK Investigational Site | Topeka | Kansas | Recruiting |
| GSK Investigational Site | Bardstown | Kentucky | Recruiting |
| GSK Investigational Site | Louisville | Kentucky | Recruiting |
| GSK Investigational Site | Haughton | Louisiana | Recruiting |
| GSK Investigational Site | Fall River | Massachusetts | Recruiting |
| GSK Investigational Site | Bingham Farms | Michigan | Recruiting |
| GSK Investigational Site | Jefferson City | Missouri | Recruiting |
| GSK Investigational Site | Lincoln | Nebraska | Recruiting |
| GSK Investigational Site | Lincoln | Nebraska | Withdrawn |
| GSK Investigational Site | Lincoln | Nebraska | Recruiting |
| GSK Investigational Site | The Bronx | New York | Recruiting |
| GSK Investigational Site | Charlotte | North Carolina | Recruiting |
| GSK Investigational Site | Monroe | North Carolina | Withdrawn |
| GSK Investigational Site | Cleveland | Ohio | Recruiting |
| GSK Investigational Site | Dayton | Ohio | Recruiting |
| GSK Investigational Site | Chickasha | Oklahoma | Recruiting |
| GSK Investigational Site | Tulsa | Oklahoma | Recruiting |
| GSK Investigational Site | Gresham | Oregon | Recruiting |
+ 57 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06740630 on ClinicalTrials.gov ↗ ← All trials in Mexico