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NCT06855160 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Chickenpox, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
- 12
- Study locations
NCT06855160: Recruiting Phase 3 study of Chickenpox, sponsored by GlaxoSmithKline.
NCT06855160 is a Phase 3 study of Chickenpox that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 900 participants, above the 541-participant average among 5 other Chickenpox trials with a reported enrollment target (66% higher). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06855160, a Phase 3 study of Chickenpox, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Candidate varicella vaccine
- BIOLOGICAL Marketed varicella vaccine
- BIOLOGICAL MMR vaccine
- BIOLOGICAL Hepatitis A vaccine
- BIOLOGICAL PCV (pneumococcal conjugate vaccine) 13
Study Locations (12)
Florida
- GSK Investigational Site - Coral Gables
- GSK Investigational Site - Miami Lakes
- GSK Investigational Site - Tampa
Texas
- GSK Investigational Site - Houston
- GSK Investigational Site - Lewisville
- GSK Investigational Site - Pharr
California
- GSK Investigational Site - Huntington Park
- GSK Investigational Site - Sherman Oaks
Arizona
- GSK Investigational Site - Tucson
Idaho
- GSK Investigational Site - Idaho Falls
Ohio
- GSK Investigational Site - Dayton
Other
- GSK Investigational Site - Alken
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 3 |
What NCT06855160 shows while recruiting
NCT06855160 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 541-participant average among 5 other Chickenpox trials with a reported enrollment target (66% higher).
The record links to 1 condition, with Chickenpox appearing as the primary indexed condition, and to 5 interventions - of which Candidate varicella vaccine is the first listed.
NCT06855160 lists 12 locations in 7 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06855160 about?
NCT06855160 is a clinical study titled "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". 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...
What is the current status of trial NCT06855160?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2025-04-17. Estimated completion is 2027-02-02.
What conditions does trial NCT06855160 study?
This clinical trial studies the following conditions: Chickenpox.
What interventions are being tested in trial NCT06855160?
The interventions under investigation include: Candidate varicella vaccine (BIOLOGICAL), Marketed varicella vaccine (BIOLOGICAL), MMR vaccine (BIOLOGICAL), Hepatitis A vaccine (BIOLOGICAL), PCV (pneumococcal conjugate vaccine) 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06855160?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06855160 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Idaho, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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