A Study on the 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: 1 dose of investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine: 1 dose of marketed varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine: 1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine: 1 dose of hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13: 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.
PCV 20: 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.
Vaxneuvance: 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Percentage of participants reporting each solicited administration site events — Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain and swelling. - Percentage of participants reporting each solicited systemic event — Day 1 (post-dose) to Day 15
Solicited systemic events include drowsiness, loss of appetite and irritability. - Percentage of participants reporting each solicited systemic event in terms of fever — Day 1 (post-dose) to Day 22
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). - Percentage of participants reporting each solicited administration site events — Day 1 (post-dose) to Day 43
Solicited administration site include injection site varicella-like rash. - Percentage of participants reporting solicited systemic events — Day 1 (post-dose) to Day 43
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like). - Percentage of participants reporting unsolicited adverse events (AEs) — Day 1 (post-dose) to Day 43
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. - Percentage of participants reporting medically attended AEs (MAAE) — Day 1 (post-dose) to Day 181 (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. - Percentage of participants reporting serious adverse events (SAEs) — Day 1 (post-dose) to Day 181 (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.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | Withdrawn |
| GSK Investigational Site | Tucson | Arizona | Withdrawn |
| GSK Investigational Site | Huntington Park | California | Recruiting |
| GSK Investigational Site | National City | California | Recruiting |
| GSK Investigational Site | West Covina | California | Recruiting |
| GSK Investigational Site | Hialeah | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Chicago | Illinois | Recruiting |
| GSK Investigational Site | El Dorado | Kansas | Withdrawn |
| GSK Investigational Site | Lafayette | Louisiana | Recruiting |
| GSK Investigational Site | Mankato | Minnesota | Recruiting |
| GSK Investigational Site | Lincoln | Nebraska | Recruiting |
| GSK Investigational Site | Cincinnati | Ohio | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | Dallas | Texas | Withdrawn |
| GSK Investigational Site | Houston | Texas | Recruiting |
| GSK Investigational Site | Richmond | Texas | Recruiting |
| GSK Investigational Site | Richmond | Texas | Recruiting |
| GSK Investigational Site | San Antonio | Texas | Withdrawn |
| GSK Investigational Site | Roy | Utah | Completed |
| GSK Investigational Site | Syracuse | Utah | Recruiting |
| GSK Investigational Site | Richmond | Virginia | Recruiting |
| GSK Investigational Site | Vienna | Virginia | Withdrawn |
| GSK Investigational Site | Burgas | Bulgaria | Withdrawn |
| GSK Investigational Site | Gabrovo | Bulgaria | Recruiting |
| GSK Investigational Site | Kyustendil | Bulgaria | Recruiting |
| GSK Investigational Site | Plovdiv | Bulgaria | Recruiting |
| GSK Investigational Site | Rousse | Bulgaria | Recruiting |
| GSK Investigational Site | Sevlievo | Bulgaria | Recruiting |
| GSK Investigational Site | Yambol | Bulgaria | Withdrawn |
| GSK Investigational Site | Aarhus N | Denmark | Recruiting |
| GSK Investigational Site | Copenhagen | Denmark | Recruiting |
| GSK Investigational Site | Hvidovre | Denmark | Recruiting |
| GSK Investigational Site | Odense C | Denmark | Recruiting |
| GSK Investigational Site | Tallinn | Estonia | Recruiting |
| GSK Investigational Site | Tallinn | Estonia | Recruiting |
| GSK Investigational Site | Hong Kong | Hong Kong | Recruiting |
| GSK Investigational Site | Shatin | Hong Kong | Recruiting |
| GSK Investigational Site | Kaunas | Lithuania | Recruiting |
| GSK Investigational Site | Kaunas | Lithuania | Recruiting |
+ 6 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Poland
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 NCT06693895 on ClinicalTrials.gov ↗ ← All trials in Poland