A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
Candidate varicella vaccine: Investigational varicella vaccine administered intramuscularly.
Marketed varicella vaccine: Marketed varicella vaccine administered subcutaneously.
MMR vaccine: MMR vaccine 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 Vaxneuvancewill 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
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
Eligibility
Primary outcome measure(s)
- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) — At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold. - Geometric Mean Concentration (GMC) of anti-VZV gE IgG — At Day 43
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group. - Percentage of participants with seroresponse to MMR antigens — At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold. - GMC of Anti-measles antibodies — At Day 43
- GMC of Anti-mumps antibodies — At Day 43
- GMC of Anti-rubella antibodies — At Day 43
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | Recruiting |
| GSK Investigational Site | Huntington Park | California | Recruiting |
| GSK Investigational Site | Sherman Oaks | California | Recruiting |
| GSK Investigational Site | Coral Gables | Florida | Recruiting |
| GSK Investigational Site | Miami Lakes | Florida | Recruiting |
| GSK Investigational Site | Tampa | Florida | Recruiting |
| GSK Investigational Site | Idaho Falls | Idaho | Recruiting |
| GSK Investigational Site | Dayton | Ohio | Recruiting |
| GSK Investigational Site | Houston | Texas | Recruiting |
| GSK Investigational Site | Lewisville | Texas | Recruiting |
| GSK Investigational Site | Mansfield | Texas | Recruiting |
| GSK Investigational Site | Pharr | Texas | Recruiting |
| GSK Investigational Site | Richmond | Virginia | Recruiting |
| GSK Investigational Site | Alken | Belgium | Recruiting |
| GSK Investigational Site | Tartu | Estonia | Recruiting |
| GSK Investigational Site | Athens | Greece | Withdrawn |
| GSK Investigational Site | Athens | Greece | Recruiting |
| GSK Investigational Site | Thessaloniki | Greece | Recruiting |
| GSK Investigational Site | Trzebnica | Poland | Recruiting |
| GSK Investigational Site | Brasov | Romania | Recruiting |
| GSK Investigational Site | Calarasi | Romania | Recruiting |
| GSK Investigational Site | Chiang Mai | Thailand | Recruiting |
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 NCT06855160 on ClinicalTrials.gov ↗ ← All trials in Poland