Actively Recruiting
A Phase 3a, Observer-blind, Randomized Study Comparing the Safety of an Investigational Varicella Vaccine to Varivax in Healthy Children 12 to 15 Months Old
Led by GlaxoSmithKline · Updated on 2026-05-29
750
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of an investigational varicella vaccine (VNS Vaccine) compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella (MMR) vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine (PCV), which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.
CONDITIONS
Brief Title
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal representative willing and able to comply with study requirements
- Written informed consent obtained before any study procedure
- Healthy child based on medical history and exam
- Male or female aged 12 to 15 months at vaccination
- For countries recommending PCV at this age: prior completion of primary PCV series with last dose at least 60 days before study entry
You will not qualify if you...
- History of allergic reaction to any vaccine component
- Immunosuppressive or immunodeficient condition
- Hypersensitivity to latex
- Recurrent uncontrolled neurological disorders or seizures
- History of chickenpox disease
- Active untreated tuberculosis
- Any condition posing additional risk as judged by investigator
- Use of investigational or non-registered products within 30 days before vaccination
- Planned vaccines within 30 days before to 43 days after study vaccination, except inactivated influenza vaccine
- Chronic use of immune-modifying drugs or planned use up to study end
- Previous vaccination against measles, mumps, rubella, hepatitis A, or varicella
- For countries recommending PCV: previous booster dose of PCV
- Participation in another clinical study with investigational or non-investigational intervention
- Child in care
- Immediate family or household members of study personnel
- Household members who are immunocompromised, pregnant without varicella history, or newborn infants without maternal varicella history
- Newborn infants born before 28 weeks of gestation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive one dose of an investigational or marketed varicella vaccine along with co-administered vaccines on Day 1.
1 vaccination visit (in-person)
Duration - Up to 181 days after vaccination
Participants are monitored for safety and adverse events following vaccination.
Multiple follow-up visits up to Day 181
Trial Site Locations
Total: 46 locations
1
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Withdrawn
2
GSK Investigational Site
Tucson, Arizona, United States, 85741
Withdrawn
3
GSK Investigational Site
Huntington Park, California, United States, 90057
Actively Recruiting
4
GSK Investigational Site
National City, California, United States, 91950
Actively Recruiting
5
GSK Investigational Site
West Covina, California, United States, 91790
Actively Recruiting
6
GSK Investigational Site
Hialeah, Florida, United States, 33012
Actively Recruiting
7
GSK Investigational Site
Miami, Florida, United States, 33142
Actively Recruiting
8
GSK Investigational Site
Chicago, Illinois, United States, 60621
Actively Recruiting
9
GSK Investigational Site
El Dorado, Kansas, United States, 67042
Withdrawn
10
GSK Investigational Site
Lafayette, Louisiana, United States, 70508
Actively Recruiting
11
GSK Investigational Site
Mankato, Minnesota, United States, 56002
Actively Recruiting
12
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Actively Recruiting
13
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
Actively Recruiting
14
GSK Investigational Site
Dallas, Texas, United States, 75230-2571
Actively Recruiting
15
GSK Investigational Site
Dallas, Texas, United States, 75235
Withdrawn
16
GSK Investigational Site
Houston, Texas, United States, 77065
Actively Recruiting
17
GSK Investigational Site
Richmond, Texas, United States, 77469
Actively Recruiting
18
GSK Investigational Site
Richmond, Texas, United States, 77469
Actively Recruiting
19
GSK Investigational Site
San Antonio, Texas, United States, 78244
Withdrawn
20
GSK Investigational Site
Roy, Utah, United States, 84067
Completed
21
GSK Investigational Site
Syracuse, Utah, United States, 84075
Actively Recruiting
22
GSK Investigational Site
Richmond, Virginia, United States, 23294
Actively Recruiting
23
GSK Investigational Site
Vienna, Virginia, United States, 22180
Withdrawn
24
GSK Investigational Site
Burgas, Bulgaria, 8008
Withdrawn
25
GSK Investigational Site
Gabrovo, Bulgaria, 5300
Actively Recruiting
26
GSK Investigational Site
Kyustendil, Bulgaria, 2500
Actively Recruiting
27
GSK Investigational Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
28
GSK Investigational Site
Rousse, Bulgaria, 7000
Actively Recruiting
29
GSK Investigational Site
Sevlievo, Bulgaria, 5400
Actively Recruiting
30
GSK Investigational Site
Yambol, Bulgaria, 8600
Withdrawn
31
GSK Investigational Site
Aarhus N, Denmark, 8200
Actively Recruiting
32
GSK Investigational Site
Copenhagen, Denmark, DK-2100
Actively Recruiting
33
GSK Investigational Site
Hvidovre, Denmark, 2650
Actively Recruiting
34
GSK Investigational Site
Odense C, Denmark, DK-5000
Actively Recruiting
35
GSK Investigational Site
Tallinn, Estonia, 10615
Actively Recruiting
36
GSK Investigational Site
Tallinn, Estonia, 10617
Actively Recruiting
37
GSK Investigational Site
Hong Kong, Hong Kong, 00852
Actively Recruiting
38
GSK Investigational Site
Shatin, Hong Kong
Actively Recruiting
39
GSK Investigational Site
Kaunas, Lithuania, 47116
Actively Recruiting
40
GSK Investigational Site
Kaunas, Lithuania, LT-48259
Actively Recruiting
41
GSK Investigational Site
Durango, Mexico, 34000
Actively Recruiting
42
GSK Investigational Site
Tlalpan, Mexico, 14340
Actively Recruiting
43
GSK Investigational Site
Tlalpan, Mexico, 14340
Actively Recruiting
44
GSK Investigational Site
Bydgoszcz, Poland, 85-796
Actively Recruiting
45
GSK Investigational Site
Trzebnica, Poland, 55-100
Actively Recruiting
46
GSK Investigational Site
Warsaw, Poland, 02-172
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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