Actively Recruiting
A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Immune Response and Safety of an Investigational Varicella Vaccine Compared With Varivax in Healthy Children 12 to 15 Months Old
Led by GlaxoSmithKline · Updated on 2026-05-29
1840
Participants Needed
97
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella (MMR) vaccine, hepatitis A vaccine (HAV), and a pneumococcal conjugate vaccine (PCV) which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants' immune responses by measuring antibodies against varicella zoster virus (VZV) and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.
CONDITIONS
Brief Title
A Study on the Immune Response and 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(s) or legal representatives able to comply with study requirements
- Written informed consent obtained before any study procedures
- Healthy child confirmed by medical history and exam
- Male or female aged 12 to 15 months at time of vaccination
- For countries recommending PCV at 12 to 15 months, child must have completed 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 study vaccine components
- Known or suspected immunosuppressive or immunodeficient conditions
- Allergy to latex
- Major congenital defects
- Recurrent uncontrolled neurological disorders or seizures
- History of varicella disease
- Active untreated tuberculosis
- Any condition posing additional risk as judged by investigator
- Use of investigational or non-registered products 30 days before study or planned during study
- Planned vaccination 30 days before to 43 days after study vaccines except inactivated influenza vaccine
- Chronic use or planned use of immune-modifying drugs up to study end
- Previous vaccination against MMR, hepatitis A, or varicella
- For countries recommending PCV, previous booster dose of any PCV
- Participation in another clinical study with investigational or non-investigational intervention
- Child in care
- Immediate family or household members of study personnel
- Household contacts who are immunocompromised, pregnant women without varicella history, or newborn infants without maternal varicella history
- Newborn infants born before 28 weeks gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 the varicella vaccine (either investigational or marketed), along with one dose each of MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine on Day 1.
1 vaccination visit (in-person)
Duration - Approximately 6 weeks
Participants are observed for immune response and safety outcomes following vaccination.
Visits at Day 15, Day 22, Day 43, and Day 181 (in-person)
Trial Site Locations
Total: 97 locations
1
GSK Investigational Site
Mobile, Alabama, United States, 36608
Actively Recruiting
2
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
3
GSK Investigational Site
Sherwood, Arkansas, United States, 72120
Actively Recruiting
4
GSK Investigational Site
Canoga Park, California, United States, 91304
Actively Recruiting
5
GSK Investigational Site
Covina, California, United States, 91723
Actively Recruiting
6
GSK Investigational Site
Fullerton, California, United States, 92835
Withdrawn
7
GSK Investigational Site
Long Beach, California, United States, 90807
Withdrawn
8
GSK Investigational Site
Los Angeles, California, United States, 90057
Actively Recruiting
9
GSK Investigational Site
Paramount, California, United States, 90723
Withdrawn
10
GSK Investigational Site
Sacramento, California, United States, 95823
Actively Recruiting
11
GSK Investigational Site
Ventura, California, United States, 93003
Actively Recruiting
12
GSK Investigational Site
Walnut Creek, California, United States, 94598
Actively Recruiting
13
GSK Investigational Site
Winnetka, California, United States, 91306
Actively Recruiting
14
GSK Investigational Site
Miami, Florida, United States, 33176
Withdrawn
15
GSK Investigational Site
Miami, Florida, United States, 33184
Actively Recruiting
16
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
17
GSK Investigational Site
Spring Hill, Florida, United States, 34609
Actively Recruiting
18
GSK Investigational Site
Tampa, Florida, United States, 33613
Actively Recruiting
19
GSK Investigational Site
Covington, Georgia, United States, 70433
Actively Recruiting
20
GSK Investigational Site
Ammon, Idaho, United States, 83406
Actively Recruiting
21
GSK Investigational Site
Moline, Illinois, United States, 61265
Actively Recruiting
22
GSK Investigational Site
South Bend, Indiana, United States, 46617
Actively Recruiting
23
GSK Investigational Site
Topeka, Kansas, United States, 66606
Actively Recruiting
24
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Actively Recruiting
25
GSK Investigational Site
Louisville, Kentucky, United States, 40202-1822
Actively Recruiting
26
GSK Investigational Site
Haughton, Louisiana, United States, 71037
Actively Recruiting
27
GSK Investigational Site
Fall River, Massachusetts, United States, 02721-1735
Actively Recruiting
28
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Actively Recruiting
29
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Actively Recruiting
30
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Actively Recruiting
31
GSK Investigational Site
Lincoln, Nebraska, United States, 68510
Withdrawn
32
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Actively Recruiting
33
GSK Investigational Site
The Bronx, New York, United States, 10456
Actively Recruiting
34
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
Actively Recruiting
35
GSK Investigational Site
Monroe, North Carolina, United States, 28112
Withdrawn
36
GSK Investigational Site
Cleveland, Ohio, United States, 44121
Actively Recruiting
37
GSK Investigational Site
Dayton, Ohio, United States, 45424
Actively Recruiting
38
GSK Investigational Site
Chickasha, Oklahoma, United States, 73018
Actively Recruiting
39
GSK Investigational Site
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
40
GSK Investigational Site
Gresham, Oregon, United States, 97030
Actively Recruiting
41
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Actively Recruiting
42
GSK Investigational Site
Charleston, South Carolina, United States, 29414
Actively Recruiting
43
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Actively Recruiting
44
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Actively Recruiting
45
GSK Investigational Site
Beaumont, Texas, United States, 77701
Actively Recruiting
46
GSK Investigational Site
Burleson, Texas, United States, 76028
Withdrawn
47
GSK Investigational Site
Corpus Christi, Texas, United States, 78404
Actively Recruiting
48
GSK Investigational Site
Dallas, Texas, United States, 75230-2571
Actively Recruiting
49
GSK Investigational Site
Dallas, Texas, United States, 75251
Withdrawn
50
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
51
GSK Investigational Site
Houston, Texas, United States, 77087
Actively Recruiting
52
GSK Investigational Site
McAllen, Texas, United States, 78504
Actively Recruiting
53
GSK Investigational Site
Mesquite, Texas, United States, 75149
Actively Recruiting
54
GSK Investigational Site
Layton, Utah, United States, 84041
Actively Recruiting
55
GSK Investigational Site
Layton, Utah, United States, 84041
Completed
56
GSK Investigational Site
Murray, Utah, United States, 84107
Actively Recruiting
57
GSK Investigational Site
Pleasant View, Utah, United States, 84404
Actively Recruiting
58
GSK Investigational Site
South Jordan, Utah, United States, 84095
Actively Recruiting
59
GSK Investigational Site
West Jordan, Utah, United States, 84088
Withdrawn
60
GSK Investigational Site
Richmond, Virginia, United States, 23226
Actively Recruiting
61
GSK Investigational Site
Brussels, Belgium, 1200
Actively Recruiting
62
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
63
GSK Investigational Site
Gozée, Belgium, 6534
Actively Recruiting
64
GSK Investigational Site
Leuven, Belgium, 3000
Actively Recruiting
65
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
66
GSK Investigational Site
Cali, Colombia, 760042
Actively Recruiting
67
GSK Investigational Site
Medellín, Colombia, 050021
Actively Recruiting
68
GSK Investigational Site
Jindřichův Hradec, Czechia, 377 01
Actively Recruiting
69
GSK Investigational Site
Jindřichův Hradec, Czechia, 37701
Actively Recruiting
70
GSK Investigational Site
Jinočany, Czechia, 530 12
Actively Recruiting
71
GSK Investigational Site
Ostrava, Czechia, 708 00
Actively Recruiting
72
GSK Investigational Site
Prague, Czechia, 160 00
Actively Recruiting
73
GSK Investigational Site
Santo Domingo, Dominican Republic, 10201
Actively Recruiting
74
GSK Investigational Site
Santo Domingo, Dominican Republic, 10205
Actively Recruiting
75
GSK Investigational Site
Santo Domingo Oeste, Dominican Republic, 11114
Actively Recruiting
76
GSK Investigational Site
Paide, Estonia, 72713
Actively Recruiting
77
GSK Investigational Site
Tartu, Estonia, 50106
Actively Recruiting
78
GSK Investigational Site
Acapulco, Mexico, 39670
Actively Recruiting
79
GSK Investigational Site
Hidalgo, Mexico, 42000
Actively Recruiting
80
GSK Investigational Site
Mexico City, Mexico, 6750
Actively Recruiting
81
GSK Investigational Site
Mexico City, Mexico
Actively Recruiting
82
GSK Investigational Site
Veracruz, Mexico, 91900
Actively Recruiting
83
GSK Investigational Site
Bydgoszcz, Poland, 85-048
Actively Recruiting
84
GSK Investigational Site
Częstochowa, Poland, 42-217
Actively Recruiting
85
GSK Investigational Site
Krakow, Poland, 30-363
Actively Recruiting
86
GSK Investigational Site
Siemianowice Śląskie, Poland, 41103
Actively Recruiting
87
GSK Investigational Site
Torun, Poland, 87-100
Actively Recruiting
88
GSK Investigational Site
Caguas, Puerto Rico, 00725
Actively Recruiting
89
GSK Investigational Site
Ponce, Puerto Rico, 00716
Actively Recruiting
90
GSK Investigational Site
San Juan, Puerto Rico, 00918
Actively Recruiting
91
GSK Investigational Site
San Juan, Puerto Rico, 907
Actively Recruiting
92
GSK Investigational Site
Bangkok, Thailand, 10700
Actively Recruiting
93
GSK Investigational Site
Rajathevee, Thailand, 10400
Actively Recruiting
94
GSK Investigational Site
Abu Dhabi, United Arab Emirates
Actively Recruiting
95
GSK Investigational Site
Abu Dhabi, United Arab Emirates
Actively Recruiting
96
GSK Investigational Site
Abu Dhabi, United Arab Emirates
Actively Recruiting
97
GSK Investigational Site
Al Ain City, United Arab Emirates
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
5
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