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NCT06740630 · ClinicalTrials.gov registry record · Phase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given 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
- 1,840
- Enrollment target
- 5
- Study locations
NCT06740630: Recruiting Phase 3 study of Chickenpox, sponsored by GlaxoSmithKline.
NCT06740630 is a Phase 3 study of Chickenpox that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 1,840 participants, above the 353-participant average among 5 other Chickenpox trials with a reported enrollment target (421% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06740630, a Phase 3 study of Chickenpox, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,840 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
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 g
Conditions Studied
Interventions
- BIOLOGICAL Investigational varicella vaccine_Lot 1
- BIOLOGICAL Investigational varicella vaccine_Lot 2
- BIOLOGICAL Investigational varicella vaccine_Lot 3
- BIOLOGICAL Marketed varicella vaccine_Lot 1
- BIOLOGICAL Marketed varicella vaccine_Lot 2
Study Locations (5)
Utah
- GSK Investigational Site - Layton
- GSK Investigational Site - Layton
Florida
- GSK Investigational Site - Tampa
Michigan
- GSK Investigational Site - Bingham Farms
Texas
- GSK Investigational Site - McAllen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,840 participants |
| Start Date | 2025-01-10 |
| Est. Completion | 2027-05-13 |
| Phase | Phase 3 |
What NCT06740630 shows while recruiting
NCT06740630 is an interventional study that assigns participants to a tested intervention. Its 1,840 participants enrollment target places it among the larger protocols in the corpus, above the 353-participant average among 5 other Chickenpox trials with a reported enrollment target (421% higher).
The record links to 1 condition, with Chickenpox appearing as the primary indexed condition, and to 5 interventions - of which Investigational varicella vaccine_Lot 1 is the first listed.
NCT06740630 lists 5 locations in 4 states (Utah, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT06740630 about?
NCT06740630 is a clinical study titled "A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age". 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 c...
What is the current status of trial NCT06740630?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,840 participants. The study started on 2025-01-10. Estimated completion is 2027-05-13.
What conditions does trial NCT06740630 study?
This clinical trial studies the following conditions: Chickenpox.
What interventions are being tested in trial NCT06740630?
The interventions under investigation include: Investigational varicella vaccine_Lot 1 (BIOLOGICAL), Investigational varicella vaccine_Lot 2 (BIOLOGICAL), Investigational varicella vaccine_Lot 3 (BIOLOGICAL), Marketed varicella vaccine_Lot 1 (BIOLOGICAL), Marketed varicella vaccine_Lot 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06740630?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06740630 being conducted?
This trial has 5 study locations across Florida, Michigan, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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